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FDA Accepts New Drug Application for Kidney Disease Therapy Tolvaptan

Review set for September (Apr. 12)

April 12, 2013

The FDA has accepted for priority review a new drug application (NDA) for the potential use of tolvaptan (Otsuka Pharmaceutical Co.) for the treatment of autosomal-dominant polycystic kidney disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published online in the New England Journal of Medicine.

ADPKD is a hereditary genetic illness characterized by the development of multiple cysts in the kidneys. It is the most common inherited kidney disease and the fourth most common overall cause of kidney failure worldwide. The diagnosed prevalence is estimated to be between 1:1,000 and 1:4,000 globally.

Tolvaptan is a selective V2 vasopressin receptor antagonist that is believed to slow the progression of ADPKD by reducing the development and growth of kidney cysts. These cysts are characteristic of ADPKD and are often associated with pain, hypertension, decreased kidney function, and, ultimately, kidney failure.

The FDA target action date (PDUFA date) for the new NDA is September 1, 2013.

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